跳至主要内容
临床试验/NCT02795936
NCT02795936已完成不适用

Feasibility of Cardiac Rehabilitation in Patients With Heart Failure at the Moi Teaching and Referral Hospital

Duke University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Protocol adherence

研究概览

简要总结

This is a study to find out whether cardiac rehabilitation is feasible in Western Kenya.

This study will test whether cardiac rehabilitation is feasible by measuring how many participants are able to follow and complete two different exercise protocols; one at home and one in hospital. It will also measure how the exercise intervention affects quality of living, depression and improvement in exercise tolerance.

详细描述

Cardiovascular diseases are major drivers of global disease burden. Heart failure, has a 50% mortality at 5 years and is thought to be higher in resource limited settings. Cardiac rehabilitation (CR) is a multi-disciplinary intervention which has been demonstrated to improve functional status, quality of life, and reduce morbidity and mortality in patients with heart failure. In sub-Saharan Africa, despite a significant heart failure disease burden, CR is largely non-existent. There is a compelling need for urgent development of access to CR in the region. However, feasibility and potential utilization of CR is unknown. The investigators aim to conduct a mixed methods study to evaluate feasibility of home based and institution based CR.

Participants will be voluntarily recruited from a convenience sample at the Moi Teaching and Referral Hospital (MTRH) outpatient cardiology clinic. Based on a reasonable estimate of expected subject recruitment over the time frame of study, 25 patients will be recruited into the institution based cardiac rehabilitation (IBCR) arm. In consideration of the potentially larger population and a wider geographical spread of home based cardiac rehabilitation (HBCR), 36 patients will be recruited to the HBCR arm and 40 patients will be recruited into an observational arm. While the study is not designed to make comparative outcome inferences between the HBCR and the IBCR groups, the sample size will be large enough to detect a clinically significant mean post intervention increase in 6 minute walk time distance in the HBCR arm of 50m.

The participants will be involved in physical exercises, nutritional counseling and educational sessions. Upon completion of the rehabilitation protocols, patients from both study arms will also be invited to participate in focus group discussions. Data will be analyzed and numeric data will be expressed as number (percent), means (standard deviation) or median (interquartile range). Wilcoxon rank-sum and Fisher's exact tests for pre - post intervention comparisons of continuous and binary variables, respectively. Focus group discussions will be transcribed and analyzed to identify discussion themes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • New York Heart Association (NYHA) Class II and III heart failure
  • Have had an echocardiographic study in the past 5 years
  • Owns a mobile telephone
  • Can participate in exercise
  • Can read/ primary care giver can read in English or Kiswahili
  • Can travel to hospital three times a week

排除标准

  • Recent acute illness requiring hospitalization or initiation of new medication in the preceding 4 weeks
  • Limitation of activity because of factors other than fatigue or exertional dyspnea, such as arthritis, claudication in the legs, angina, advanced comorbidities
  • Known arrhythmia
  • Heart failure due to congenital heart disease
  • Pregnant patients as may be confirmed by patient report or urine pregnancy tests
  • Heart failure due to obstructive cardiomyopathy including mitral stenosis and aortic stenosis
  • Presence of implanted pacemaker

研究组 & 干预措施

Observational arm

Placebo Comparator

No prescribed exercises, followed up monthly

干预措施: Cardiac rehabilitation (Procedure)

Home based rehabilitation

Active Comparator

Conduct cardiac rehabilitation exercise protocol at home

干预措施: Cardiac rehabilitation (Procedure)

Institutional based rehabilitation

Active Comparator

Conduct cardiac rehabilitation exercise protocol within the hospital

干预措施: Cardiac rehabilitation (Procedure)

结局指标

主要结局

Protocol adherence

时间窗: 12 weeks

Mean adherence of at least 25% to the exercise prescriptions

次要结局

  • Change in 6 minute walk time distance (in meters)(baseline, 12 weeks)
  • Change in Depression screen score using patient health questionnaire 9 (PHQ9)(baseline, 12 weeks)
  • Change in Quality of life using short form health survey (SF 36) score(baseline, 12 weeks)
  • Qualitative assessment of perceptions towards cardiac rehabilitation from focus group discussions(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Feasibility of Cardiac Rehabilitation in Patients... | 临床试验